Tool Assembly for Harvesting and Implanting Follicular Units

ABSTRACT

A multi-part tool assembly for harvesting and implanting follicular units, comprising an outer cannula having an open, tissue-piercing distal end, and an inner cannula coaxially positioned in a lumen of the first cannula, the second cannula having an open, tissue-coring distal end sized to engage and retain single hair follicular units. An obturator may be positioned in the lumen of the second cannula, wherein at least one of the first cannula, second cannula, and obturator are movable relative to the other ones.

RELATED APPLICATION DATA

The present application is a continuation of co-pending application Ser.No. 11/421,438, entitled “Tool Assembly for Harvesting and ImplantingFollicular Units,” filed May 31, 2006, which in turn claims the benefitunder 35 U.S.C. §119 to U.S. provisional patent application Ser. Nos.60/722,521, filed Sep. 30, 2005, 60/753,602, filed Dec. 22, 2005, and60/764,173, filed Jan. 31, 2006, which are all hereby incorporated byreference.

FIELD OF INVENTION

This invention relates generally to apparatus used for harvesting andimplantation of hair follicular units.

BACKGROUND

Hair transplantation procedures are well-known, and typically involve(in a patient having male pattern baldness) harvesting donor hair graftsfrom the side and back fringe areas (donor areas) of the patient'sscalp, and implanting them in a bald area (recipient area).Historically, the harvested grafts were relatively large (3-5 mm),although more recently, the donor grafts may be single follicular units.In particular “follicular units” are naturally occurring aggregates of1-3 (and much less commonly, 4-5) closely spaced hair follicles that aredistributed randomly over the surface of the scalp. In one well-knownprocess, a linear portion of the scalp is removed from a donor area bydissection with a scalpel down into the fatty subcutaneous tissue. Thestrip is dissected (under a microscope) into the component follicularunits, which are then implanted into a recipient area in respectivepuncture holes made by a needle. Forceps are typically used to grasp andplace the follicular unit grafts into the needle puncture locations,although other instruments and methods are known for doing so.

In “Androgenetic Alopecia” (Springer 1996), M. Inaba & Y. Inaba discloseand describe a method for harvesting singular follicular units bypositioning a hollow punch needle having a cutting edge and interiorlumen with a diameter of 1 mm, which is about equal to the diameter ofcritical anatomical parts of a follicular unit. The needle punch isaxially aligned with an axis of a follicular unit to be extracted andthen advanced into the scalp to cut the scalp about the circumference ofthe selected follicular unit. Thereafter, the follicular units areeasily removed, e.g., using forceps, for subsequent implantation into arecipient site with a specially devised insertion needle.

Published U.S. Patent Application 20050203545 (Cole) discloses aninstrument for the extraction of individual follicular units thatpurportedly allows for a more precise penetration depth and angle withrespect to the skin surface of the skin of a patient.

Published U.S. Patent Application 20050267506 (Harris) discloses amethod and apparatus for the extraction of follicular units by firstscoring the outer skin layers with a sharp punch, and then inserting aseparate blunt punch into the incision to separate the hair follicularunit from the surrounding tissue and fatty layer.

U.S. Pat. No. 6,585,746 (Gildenberg) discloses a hair transplantationsystem utilizing a robotic system, including a robotic arm and a hairfollicle introducer associated with the robotic arm. A video system isused to produce a three-dimensional virtual image of the patient'sscalp, which is used to plan the scalp locations that are to receivehair grafts implanted by the follicle introducer under the control ofthe robotic arm. The entire disclosure of U.S. Pat. No. 6,585,746 isincorporated herein by reference.

SUMMARY

In accordance with one aspect of the invention, a multi-part toolassembly is provided for the harvesting and implantation of hairfollicular units in a body surface, such as a human scalp. In oneembodiment, the tool assembly comprises a pair of coaxially disposedcannulas positioned in a reciprocating relationship, including an outer“implanting” cannula having an interior lumen and an open,tissue-piercing distal end, and an inner “harvesting” cannula positionedin the implanting cannula lumen. The harvesting cannula has an open,tissue-coring distal end, and an interior lumen sized to frictionallyengage and retain a follicular unit.

The tool assembly may be hand-held and positioned. In the alternative,the tool assembly may be attached to, and positioned by, a moveable armof an automated system, e.g., a robotic arm system. Movement of one orboth of the harvesting and implanting cannulas relative to each otherand/or to the remainder of the tool assembly (whether hand-held orcarried by an automated positioning system) may be provided by a numberof different mechanical, electro-mechanical, pneumatic, hydraulic,magnetic, and other known systems and mechanisms for effectingcontrolled movement of the respective cannulas. While the implanting andharvesting cannulas are preferably axially aligned, other embodimentsare possible.

For harvesting, a longitudinal axis of the harvesting cannula is axiallyaligned with a longitudinal axis of a selected follicular unit to beharvested. Depending on the embodiment, positioning of the harvestingcannula relative to the selected follicular unit may be manual or fullyautomated. In one embodiment, an image-guided robotic system including arobotic arm is used to position and align the respective harvestingcannula and follicular unit. The harvesting cannula is advanced over thefollicular unit, with its distal coring end penetrating the body surfaceinto the subcutaneous fatty layer surrounding and underlying thefollicular unit. The harvesting cannula is then withdrawn from the bodysurface to thereby extract the follicular unit, which is carried in theharvesting cannula lumen.

Movement of the harvesting cannula relative to the body surface may bemanual, semi-automated, or completely automated. The harvesting cannulamay be fixed or independently moveable relative to the remainder of thetool assembly, whether the tool assembly is hand-held or attached to amoveable arm. In embodiments in which the tool assembly is carried on anautomated (e.g., robotic) arm, movement of the harvesting cannularelative to the body surface may be performed by movement of the armrelative to the body surface, movement of the harvesting cannularelative to the automated arm, or a combination of each. Similarly, inhand-held embodiments, movement of the harvesting cannula relative tothe body surface may be performed by movement of the operator's armrelative to the body surface, movement of the harvesting cannularelative to the tool assembly, or a combination of each. In someembodiments, the harvesting cannula is rotated about its longitudinalaxis as it penetrates the body surface to enhance its tissue-coringeffectiveness.

In some embodiments, the wall of the harvesting cannula lumen may betextured in order to facilitate grasping and extracting the follicularunit. In some embodiments, a vacuum source may be selectively placed incommunication with the harvesting cannula lumen to apply a proximallydirected “pulling” force to facilitate grasping and extracting thefollicular units. These features may also be helpful in retaining thefollicular unit in the harvesting cannula lumen after it is harvested.

For implantation, the tool assembly is repositioned (whether manually orby using an automated system) to a selected implantation site in arecipient area on the body surface. A longitudinal axis of theimplanting cannula may be aligned with a desired orientation of thefollicular unit, when implanted. Again, this alignment may be performedmanually or by an automated system, e.g., by using an image-guidedrobotic system in one embodiment. The tissue-piercing distal end of theimplanting cannula is advanced into the body surface, creating asubcutaneous implantation cavity of an appropriate depth and size forreceiving a follicular unit being implanted. This “puncture motion” bythe implanting cannula is preferably very rapid in order to minimizetrauma to the tissue surface in the implantation cavity, e.g., akin tothe motion of a spring-loaded finger pricking device used for obtainingsmall amounts of blood for testing.

In one embodiment, a follicular unit is moved axially from theharvesting cannula lumen (where it has remained undisturbed since it washarvested) into the distal end portion of the implanting cannula lumenby an obturator (plunger) disposed in the harvesting cannula lumen. Thisrepositioning of the follicular unit may take place before, during, orafter the implanting cannula punctures the body surface. The obturatorthereafter maintains the relative position of the follicular unit in theimplantation cavity as the implanting cannula is withdrawn from the bodysurface by translational movement relative to the obturator. In othersembodiment, the follicular unit is deposited directly from theharvesting cannula lumen into the implantation cavity, e.g., by theobturator, or by applying a distally directed “pushing” force using asource of pressured air placed in communication with the harvestingcannula lumen.

Other and further embodiments, objects and advantages of the inventionwill become apparent from the following detailed description when readin view of the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention are illustrated by way of example and notlimitation in the figures of the accompanying drawings, in which likereferences indicate similar elements, and in which:

FIG. 1 is a perspective view of a robotic arm system used forpositioning and orienting a pair of coaxially-disposed cannulasextending from a distal opening of a tool assembly housing carried bythe robotic arm and used for harvesting and implanting human hairfollicular units.

FIG. 2 is a close-up of the distal portion of the tool assembly housingshown in FIG. 1.

FIG. 3 is a perspective view of a multi-part tool for use in the toolassembly in the system of FIG. 1.

FIG. 4 is lengthwise sectional view of the multi-part tool of FIG. 3.

FIG. 5 is a perspective view of a motor drive assembly for operativelycoupling with the multi-part-part tool of FIG. 3 in the tool assembly ofthe system of FIG. 1.

FIGS. 6A and 6B are simplified, partially cut-away views of alternativeimplantation procedures carried out using the three-part tool of FIG. 3.

FIG. 7 is a partial-schematic, partial perspective view of oneembodiment of the tool assembly of the robotic system in FIG. 1.

FIG. 8 is a partially cut-away sectional view of a holding unit locatedwithin a motor drive assembly in the tool assembly of FIG. 7.

FIG. 9A is a lengthwise sectional view of a multi-part tool for use inthe tool assembly in the system of FIG. 7.

FIGS. 9B-9D illustrate variations of a distal end of a follicular unitharvesting cannula needle of the tool assembly of FIG. 9A.

FIG. 10 illustrates the multi-part tool of FIG. 9A operatively engagedwith the holding unit of FIG. 8.

FIGS. 11A-D illustrate a process for implanting a follicular unit, inaccordance with some embodiments.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

FIGS. 1 and 2 depict an image-guided robotics system 25, including arobotic arm 27 with a tool assembly 30 attached to a distal tool plate20. The tool assembly 30 includes coaxially disposed harvesting andimplanting cannulas 38 and 36, respectively, extending from a tubularextension 24 of a housing 22. The cannulas 36 and 38 are axially stiff,e.g., made of a hard metal or plastic, and thin-walled to facilitatetissue penetration. The implanting cannula 36 has a needle-like tissuepiecing tip, and the harvesting cannula has a tissue-coring (e.g.,serrated) tip.

As described in detail the above-incorporated provisional applicationNo. 60/764,173, the robotic arm 27 automatically and precisely positionsthe respective harvesting and implanting cannulas 38 and 36 at desiredlocations, and in desired orientations, along a body surface (e.g., ascalp) of a patient based on control signals derived at least in partfrom image data acquired by one or more cameras 28 attached to the toolassembly housing 22. Such automatic and precise positioning of therespective harvesting and implanting cannulas 38 and 36 is provided witha high degree of repeatability and accuracy (e.g., to 20 microns) byrespective motors and encoders located in respective arm joints 21 ofthe robotic arm 27. Hair transplantation generally includes three steps:follicular unit harvesting, recipient site incision, and follicular unitplacement in the incision. FIG. 3 shows one embodiment of a three-parttool 32 used for performing all three of these functions. Although theensuing description of the three-part tool 32 is with reference to itsuse as part of the tool assembly 30 carried on the robotic arm 27 in thesystem 25 of FIG. 1, it will be appreciated that hand-held and operatedembodiments of the three-part tool 32 are also possible.

More particularly, the three-part tool 32 includes an outer(“implanting”) cannula 36 having an open, tissue-piercing (e.g.,beveled) distal end 37 used for making incisions at recipient(implantation) sites in a body surface. An inner (“harvesting”) cannula38 is coaxially positioned in an interior lumen of the implantingcannula 36, and has an open, tissue-coring (e.g., rough or serrated)distal end 40. The harvesting cannula 38 has an interior lumenappropriately sized for harvesting singular human hair follicular unitsby coring the respective follicular units and extracting them from abody surface (typically but not necessarily a scalp). By way ofnon-limiting examples, embodiments of the harvesting cannula 38 may haveinterior lumens that range from approximately 0.3 millimeters to 2.0millimeters in diameter. In one embodiment, the harvesting cannula lumenhas a diameter that is approximately 1 millimeter in diameter. Notably,different sized harvesting cannulas 38 may be used for harvestingsingle-follicle follicular units than for harvesting multi-folliclefollicular units. In either case, an inner wall surface of theharvesting cannula lumen may be textured to facilitate frictionalgrasping the respective follicular units for extraction from the bodysurface after they are cored.

With reference also to FIGS. 4 and 5, the tool assembly 30 includes amotor drive assembly 60 mounted in the housing 22 and configured toreceive and operatively engage the component parts of the three-parttool 32. In particular, the implanting cannula 36 is fixedly attached toa proximal hub 34, including a distal facing tapered portion 34 a and aproximally directed engagement portion 34 b. The engagement portion 34 bmay be detachably-coupled (snap-fit) with a resilient gripper 63extending from a tubular sleeve 65 in the motor drive assembly 60. Inthe illustrated embodiment, the gripper 63 comprises a plurality ofresilient arm members 67 that are attached to or integral with, thetubular sleeve 65. It will be appreciated that other detachable couplingmechanisms may be employed in alternate embodiments. The tubular sleeve65 engages a rack-and-pinion drive mechanism 81 driven by a first motor62 of the motor drive assembly 60, so that, when the hub 34 is coupledto the gripper 63, the motor 62/drive mechanism 81 provide axial (i.e.,reciprocating) motion of the implanting cannula 36 relative to theharvesting cannula 38 (and also relative to the tool assembly housing22/24).

The harvesting cannula 38 extends proximally through a bore 45 of theimplanting cannula hub 34 and implanting cannula 36, and is fixedlyattached to distal chuck portion 43 a of a pin vise 43 seated in, androtatable relative to, a bore of hub 34. An elongate body 46 is seatedin, and fixedly attached to, the pin vise 43, and includes one or moreradially-outward extending flanges 48 that engage a corresponding set ofslots (not shown) in a distally projecting tubular drive member (notshown—extends internally through housing 93) coupled to an output gear87 driven by a second motor 64 of the motor drive assembly 60 forthereby rotating the respective elongate body 65 and harvesting cannula38, respectively, about a longitudinal axis of the harvesting cannula38. As will be appreciated, a belt drive or other means for rotating thetubular drive member (and, thereby, the harvesting cannula 38) may beused in alternative embodiments. The elongate body 46 further includes arecessed section 44 located proximally of the flanges 48, which seats anannular retaining member 50 for detachably-coupling (via a snap-fit typeconnection) with the tubular drive member (proximal of the slots thatengage flanges 48), thereby retaining the harvesting cannula 38 inposition when the tool 32 is coupled with the motor dive assembly 60.

An elongate obturator 52 is slidably positioned in an interior lumen ofthe harvesting cannula 38, and has a proximal end attached to a seatingmember 54 that engages with a linear (“screw-drive”) drive mechanism(not shown) driven by a third motor 66 of the motor drive assembly 60for selectively providing a distally-directed, “pushing” force on theobturator 52 relative to the harvesting cannula 38. A spring 53 isseated in an annular recess 49 formed in a proximal end-cap 51 of theelongate body 46, and extends (over the obturator 52) to the distal sideof the seating member 54. The spring 53 applies a proximally-directed,“pulling” force on the seating member, to thereby bias the obturatoragainst the screw drive.

The drive motor assembly further includes a “release” motor 67, thatapplies a distally-directed (pushing) force against the end-cap 51 via atubular release member 86, which causes the respective attachmentcouplings (i.e., the implanting cannula hub 34 b and gripper 63, and theharvesting cannula retaining member 50 and the tubular drive member) todecouple for removal of the tool 32 from the tool assembly 30, e.g., forreplacing one or both of the implanting and harvesting cannulas 36 and38. In this manner, the multi-part tool 32 may be loaded into the toolassembly 30 by insertion (in the proximal direction) of the tool 32(“back loaded”) through the tubular extension 24 of the housing 22,until the respective couplings 34 b and 50 snap into place with theircounterparts in the motor drive assembly 60, and released by applicationof a sufficient force by the motor 67 on the release member 86 todecouple the respective couplings. A stop member 55 is attached to theobturator 52 that abuts the distal side of the end-cap as the releasemember 86 applies a downward force on the end-cap 51, so that theobturator 52 accompanies the rest of the tool 32 as it is released fromthe motor drive assembly 60 (and from the tool assembly 30).

The motor drive assembly 60 further comprises control circuitry forcontrolling operation of the respective motors 62, 64, 66, and 67. Thecontrol circuitry may include an independent processor (not shown)associated with the motor drive assembly 60, which receives as inputsinformation from the robotic system 25, including but not limited topositioning data obtained from images acquired of the respectivecannulas 36, 38 and body surface/objects (e.g., hair follicles).Additionally or alternatively, a respective encoder may be operativelycoupled with one or more of the motors 62, 64, 66, and 67 for trackingthe relative movement and, thus, position information, of the implantingcannula 36, harvesting cannula 38, and/or obturator 52.

For harvesting a follicular unit from a body surface (e.g., a scalp),the robotic arm 27 positions and aligns the harvesting cannula 38 with alongitudinal axis of a selected follicular unit to be harvested. Theharvesting cannula 38 is then advanced over the selected follicular unitby motion of the robotic arm 27, accompanied by simultaneous rotationalmovement of the harvesting cannula 38 about its longitudinal axis by themotor 64, with the open distal end 40 of the cannula 38 penetrating thebody surface into the subcutaneous fatty layer surrounding andunderlying the follicular unit. In alternate embodiments, a linear drivemechanism may be additionally provided in the motor drive assembly 60for providing independently controlled axial translation of theharvesting cannula 38 relative to the tool assembly housing 20 (andimplanting cannula 36). The harvesting cannula 38 is then withdrawn fromthe body surface by motion of the robotic arm 27 to thereby extract thefollicular unit, which is carried in the lumen of the harvestingcannula. In some embodiments, a vacuum source may be selectively placedin communication with the harvesting cannula lumen to apply aproximally-directed “pulling” force to facilitate grasping andextracting the follicular unit, as well as to help retain the follicularunit in the harvesting cannula lumen after it has been harvested.

For implantation, the tool assembly 30 is repositioned by the roboticarm 27 to a selected implantation site on the body surface. At theimplantation site, a longitudinal axis of the implanting cannula 36 ispreferably aligned with a desired orientation of the follicular unit,when implanted. With reference to FIGS. 6A-B, the tissue-piercing distalend 37 of the implanting cannula 36 is advanced over the harvestingcannula 38 and into the body surface 68, creating a subcutaneousimplantation cavity 70 of an appropriate depth and size for receivingthe harvested follicular unit 72. This puncture motion by the cannula 36is automatically controlled by motor 62, and is preferably very rapid inorder to minimize trauma to the tissue surface 74 of the implantationcavity 70.

In one embodiment (shown in FIG. 6A), the follicular unit 72 is movedaxially by the obturator 52 (under the control of motor 66) from theharvesting cannula lumen 76, where it has remained undisturbed since itwas harvested, into a distal end portion of the implanting cannula lumen78. This repositioning of the follicular unit 72 from the harvestingcannula lumen 76 into the implanting cannula lumen 78 may take placebefore, during, or after the implanting cannula 36 has punctured thebody surface 68. The obturator thereafter maintains the follicular unit72 in the implantation cavity 70 as the implanting cannula 36 iswithdrawn from the body surface 68 by translational movement relative tothe obturator 52. Once the implanting cannula 36 is withdrawn, theobturator 52 is also withdrawn, with the follicular unit 72 implanted inthe body surface. A distal facing end 80 of the obturator 52 ispreferably recessed to allow room for one or more hair follicles 82protruding from the follicular unit 72.

In another embodiment (shown in FIG. 6B), the respective distal ends ofthe implanting and harvesting cannulas 36 and 38 are aligned (i.e., byrelative movement of the implanting cannula 36) so that their respectivedistal ends 37 and 40 are approximately coextensive. This alignment ofthe respective cannula distal ends 37 and 40 may take place before,during, or after the implanting cannula penetrates the body surface toform the implantation cavity 70. Thereafter, the respective cannulas 36and 38 are withdrawn from the implantation cavity 70, while thefollicular unit 72 is retained therein, i.e., by simultaneous movementof the robotic arm 27 away from the body surface 68 and of the obturator52 towards the body surface 68. In alternate embodiments having a lineardrive mechanism in the motor drive assembly 60 for providingindependently controlled axial translation of the harvesting cannula 38relative to the tool assembly housing 20 (and implanting cannula 36),the respective cannulas 36 and 38 may be withdrawn from the implantationcavity 70 relative to (and without requiring simultaneous movement of)the obturator 52 by operation of the motor drive assembly 60. In otheralternate embodiments, a source of pressurized air selectively placed incommunication with the harvesting cannula lumen 76 may be used to retainthe follicular unit 72 in the implantation cavity 70 as the cannulas 36and 38 are withdrawn.

FIG. 7 illustrates a distal portion of the robotics system 25 inaccordance with some embodiments of the invention. A force sensor 100 issecured to an arm 104, a plate 102 mounted to the force sensor 100, anda motor drive, or “positioning” assembly 106 secured to the plate 102.Alternatively, the plate 102 could be secured directly to the arm 104,in which cases, the force sensor 100 may be secured between thepositioning assembly 106 and the plate 102. Alternatively, the forcesensor 100 may be located within the positioning assembly 106. The forcesensor 100 is configured to sense three forces Fx, Fy, Fz in threedifferent orthogonal directions X, Y, Z, and three orthogonal momentsMx, My, Mz. In other embodiments, the force sensor 100 may be configuredto sense one or two of the forces Fx, Fy, Fz, and/or one or two of themoments Mx, My, Mz. As shown in the figure, the force sensor 100 iscoupled to a computer 120, which receives data from the force sensor 100representing the sensed force(s) and/or moment(s). In other embodiments,the force sensor data may go directly to the robot.

During the above harvesting and implanting process, the force sensor 100monitors one or more force/moment component transmitted from thepositioning assembly 106. For example, the force sensor 100 may monitora force Fz, which has a directional vector that is approximatelyparallel to an axis of a harvesting cannula 200. The sensed force Fz istransmitted to the computer 120, which determines whether a magnitude ofthe sensed force Fz is within an acceptable limit. In some embodiments,the computer 120 is configured (e.g., programmed) to stop a harvestprocess or an implant process if the sensed force Fz exceeds aprescribed limit, which may indicate that the harvesting cannula 200 orthe implanting cannula 202 is pressing against the skull, for example.As such, the force sensor 100 provides a safety feature that preventsthe harvesting cannula 200 and the implanting cannula 202 from injuringa patient in an unintended way.

In the illustrated embodiments, the positioning assembly 106 includes aholding unit 109 for engagement with a cannula assembly 110, and aplurality of positioners 107 a-107 c. The holding unit 109 is configuredto engage with different parts of the cannula assembly 110 so that thecannula assembly 110, as a whole, can be positioned by the positioningassembly 106. The holding unit 109 also allows different components ofthe cannula assembly 110 to be controlled after the cannula assembly 110is engaged with the holding unit 109. The positioners 107 a-107 c areconfigured for moving different components of the cannula assembly 110after it has been engaged with the holding unit. Although threepositioners 107 a-107 c are shown, in other embodiments, the positioningassembly 106 may include more or less than three positioners 107. Insome embodiments, the positioning assembly 106 may include the motordrive assembly of FIG. 5, which includes three motors (positioners) formoving different components of the cannula assembly 110, plus anadditional motor for disengaging the cannula assembly 110 from thepositioning assembly.

FIG. 8 illustrates the holding unit 109 in accordance with someembodiments. The holding unit 109 includes a first engagement portion122 for engaging a first portion of the cannula assembly 110, a secondengagement portion 124 for engaging a second portion of the cannulaassembly 110, and a third engagement portion 126 for engaging a thirdportion of the cannula assembly 110.

FIG. 9A illustrates the cannula assembly 110 in accordance with someembodiments. The cannula assembly 110 has a similar configuration as thetool 32 shown in FIGS. 3-4. The cannula assembly 110 includes aharvesting cannula 200, an implanting cannula 202, and a plunger(obturator) 204. The harvesting cannula 200 has a proximal end 212, adistal end 214, a body 215 extending between the proximal and distalends 212, 214, and a lumen 217 defined at least partially by the body215. In the illustrated embodiments, the lumen 217 has a cross sectionaldimension that is between 0.3 millimeter and 2.0 millimeters, and morepreferably, approximately 1 millimeter. The cannula assembly 110 furtherincludes a shaft 216 having a proximal end 218, a distal end 220, and alumen 222 extending between the proximal and distal ends 218, 220. Theproximal end 212 of the harvesting cannula 200 is secured to the distalend 220 of the shaft 216. The implanting cannula 202 has a proximal end232, a distal end 234, a body 230 extending between the proximal anddistal ends 232, 234, and a lumen 236 within the body 230. The lumen 236has a cross sectional dimension sized for accommodating at least aportion of the harvesting cannula 200, and for allowing the harvestingcannula 200 to slide relative to the implanting cannula 202. The distalend 234 of the implanting cannula 202 has a sharp tip 250 for piercingtissue.

In the illustrated embodiments, the distal end 214 of the harvestingcannula 200 has a tubular configuration (FIG. 9B). In such cases, theedge 252 of the harvesting cannula 200 may have a sharp configurationfor allowing the harvesting cannula 200 to penetrate tissue. In otherembodiments, the distal end 214 of the harvesting cannula 200 may havean arc configuration (FIG. 9C). In such cases, the ends 254 of the arcportion may have a sharp configuration for allowing the harvestingcannula 200 to cut tissue as the harvesting cannula 200 is rotated aboutits axis. In further embodiments, the distal end 214 of the harvestingcannula 200 can include a plurality of cutting portions 256, with eachcutting portion 256 having a sharp edge 258 for cutting tissue (FIG.9D). It should be noted that the distal end 214 of the harvestingcannula 200 is not limited to the examples described previously, andthat the distal end 214 can have other configurations in otherembodiments, as long as it can core tissue.

The cannula assembly 110 further includes a first engagement portion 238and a second engagement portion 240. The first engagement portion 238has a tubular configuration, and is secured to the shaft 216. The secondengagement portion also has a tubular configuration, and is secured tothe proximal end 232 of the implanting cannula 202. proximal end 232 ofthe implanting cannula 202. The first and the second engagement portions238, 240 are sized and shaped to engage with corresponding components ofthe holding unit 109. It should be noted that the first and secondengagement portions 238, 240 are not limited to the example of theconfiguration illustrated, and that the engagement portions 238, 240 canhave other configurations in other embodiments. For example, inalternative embodiments, the engagement portion 238 does not have atubular configuration. In such cases, the engagement portion 238 can bea structure that is secured to, or extends from, a surface of the shaft216. Similarly, in other embodiments, the engagement portion 240 can bea structure that is secured to, or extends from, a surface of theimplanting cannula 202, and needs not have a tubular configuration. Asshown in the figure, the cannula assembly 110 also includes a connector248 secured to the shaft 216. The connector 248 has a shape thatresembles a sphere, but may have other shapes in other embodiments.

The plunger 204 has a proximal end 242 and a distal end 244. The plunger204 is at least partially located within the lumen 217 of the harvestingcannula 200, and is slidable relative to the harvesting cannula 200. Thecannula assembly 110 further includes a spring 246 coupled to theplunger 204 for biasing the plunger 204 in a proximal direction relativeto the harvesting cannula 200. In the illustrated embodiments, theplunger 204 is described as a component of the cannula assembly 110. Inother embodiments, the plunger 204 is not a part of the cannula assembly110. For example, the plunger 204 may be a component of the positioningassembly 106.

FIG. 10 illustrates the cannula assembly 110 that has been engaged withthe positioning assembly 106. When the cannula assembly 110 is snappedonto the positioning assembly 106, the first engagement portion 122 ofthe holding unit 109 is engaged with the connector 248, the secondengagement portion 124 is engaged with the first engagement portion 238of the cannula assembly 110, and the third engagement portion 126 isengaged with the second engagement portion 240 of the cannula assembly.The connector 248 allows the cannula assembly 110 to be detachablysecured to the positioning assembly 106. The first engagement portion122 of the holding unit 109 is coupled to the first positioner 107 a. Insome embodiments, the harvesting cannula 200 is not translatable. Inalternative embodiments, the first positioner 107 a is configured totranslate (e.g., advance or retract) the harvesting cannula 200. Thesecond engagement portion 124 of the holding unit 109 is coupled to thesecond positioner 107 b, which is configured to rotate the harvestingcannula 200 about its axis. The third engagement portion 126 of theholding unit 109 is coupled to the third positioner 107 c, which isconfigured to translate (e.g., advance or retract) the implantingcannula 202.

In other embodiments, the second engagement portion 124 of the holdingunit 109 may be coupled to both the first positioner 107 a and thesecond positioner 107 b. In such cases, the first positioner 107 a isconfigured to translate the engagement portion 124 to thereby advance orretract the harvesting cannula 200, and the second positioner 107 b isconfigured to rotate the engagement portion 124 to thereby turn theharvesting cannula 200 about its axis. In further embodiments, thesecond positioner 107 b is not needed, and the cannula assembly 110 doesnot include the engagement portion 238. In such cases, the positioningassembly 106 is not configured to rotate the harvesting cannula 200, butto advance and retract the harvesting cannula 200 in a back and forththrusting motion. In still further embodiments, the third positioner 107c is not needed, and the third engagement portion 126 is fixedly securedto the holding unit 109. In such cases, the implanting cannula 202 maybe positioned by the robotic arm 27, and the harvesting cannula 200 maybe positioned relative to the implanting cannula 202 using the firstpositioner 107 a.

When using the cannula assembly 110 to harvest a follicular unit, thecannula assembly 110 is first coupled to the positioning assembly 106.Such may be accomplished manually by snapping the cannula assembly 110onto the positioning assembly 106. Alternatively, the cannula assembly110 may be held upright by a stand (not shown). In such cases, therobotic arm 27 may be used to move the positioning assembly 106 to“grab” the cannula assembly 110 from the stand. The camera(s) 28 may beused to provide information regarding a position of the cannula assembly110 to the processor 120, which controls the robotic arm 27 based on theinformation, thereby placing the positioning assembly 106 in engagementposition relative to the cannula assembly 110.

Next, a treatment plan is input into the computer 120. In someembodiments, the treatment plan is a prescribed plan designed totransplant hair follicular units from a first region (harvest region) toa target region (implant region). In such cases, the treatment plan mayinclude one or more parameters, such as a number of hair follicularunits to be removed/implanted, location of harvest region, location ofimplant region, a degree of randomness associated with targeted implantlocations, spacing between adjacent targeted implant locations, depth offollicle, depth of implant, patient identification, geometric profile ofharvest region, geometric profile of implant region, marker location(s),and density of targeted implant locations. Various techniques may beused to input the treatment plan into the computer 120. In theillustrated embodiments, the treatment plan may be input using a userinterface that includes a monitor 122 and a keyboard 124. Alternatively,the treatment plan may be input using a storage device, such as adiskette or a compact disk. In other embodiments, the treatment plan maybe downloaded from a remote server. In further embodiments, thetreatment plan may be input using a combination of the above techniques.For example, some parameters may be input into the computer 120 using adiskette, while other parameters may be input using the user interface.In some embodiments, one or more parameters of the treatment plan may bedetermined in real time (e.g., during a treatment session).

After the treatment plan has been input into the computer 120, thecomputer 120 then registers the treatment plan with a patient. In someembodiments, such may be accomplished by using the camera(s) 28 toidentify one or more markers on the patient. The marker may be areflector that is secured to the patient, an ink mark drawn on thepatient, or an anatomy of the patient. The identified marker(s) may beused to determine a position and/or orientation of a target region onthe patient. In the illustrated embodiments, the treatment plan includesa position of the harvest (or donor) region. Using input from thecamera(s) 28, the computer 120 identifies the location of the harvestregion on the patient, and a target follicular unit in the harvestregion. The computer 120 then operates the robotic arm 27 to place thedistal end 214 of the harvesting cannula 200 next to the targetfollicular unit. In some embodiments, the harvesting cannula 200 ispositioned coaxially with the target follicular unit.

Next, the harvesting cannula 200 is used to harvest the targetfollicular unit. In some embodiments, such may be accomplished byactivating a positioner within the positioning assembly 106 to rotatethe harvesting cannula 200. As the harvesting cannula 200 is rotated,the harvesting cannula 200 may be advanced distally (e.g., by activatinganother positioner within the positioning assembly 106, or by moving thepositioning assembly 106 using the robotic arm 27). In otherembodiments, the harvesting of the target follicle 302 unit may beaccomplished by thrusting the harvesting cannula 200 forward andbackward. While the harvesting cannula 200 is used to core out thefollicular unit 302, the implanting cannula 202 is located proximallyaway from the distal end 214 of the harvesting cannula 200 to therebyprevent interference with the harvesting procedure. Such may beaccomplished by advancing the harvesting cannula 200 distally relativeto the implanting cannula 202, or alternatively, by retracting theimplanting cannula 202 proximally relative to the harvesting cannula 200(if the implanting cannula 202 can be positioned).

When the distal end 214 of the harvesting cannula 200 has been advancedwithin a prescribed depth, e.g., 5 millimeter, below the skin surface,the harvesting cannula 200 is then retracted and removed from thepatient. The camera(s) 28 may be used to monitor the harvesting processto thereby determine how far the harvesting cannula 200 has beenadvanced below the skin surface 306. In some embodiments, the exteriorof the harvesting cannula 200 may include marker lines to thereby allowthe camera(s) 28 or a physician to “see” how much of the harvestingcannula 200 has been advanced into the patient. In some embodiments,surface friction at the interface between the follicular unit 302 andthe interior surface 304 within the lumen 217 will hold the follicularunit 302 as the harvesting cannula 200 is removed from the patient,thereby harvesting the follicular unit 302. In other embodiments, theinterior surface 304 can be texturized (e.g., having one or more indentsor protrusions) to thereby allow the distal end 214 to more easily holdonto the follicular unit 302 as the harvesting cannula 200 is removedfrom the patient. In further embodiments, a proximal end of the cannulaassembly 110 may be coupled to a vacuum unit (not shown) located withinthe positioning assembly 106. In such cases, the vacuum unit createssuction within the lumen 217 of the harvesting cannula 200, to therebypull the target follicular unit 302 away from its underlying tissue asthe harvesting cannula 200 is removed from the patient.

After the follicular unit 302 has been harvested, the positioningassembly 106 retracts the harvesting cannula 200 proximally until thedistal end 214 is proximal to the distal end 234 of the implantingcannula 202. Alternatively, if the implanting cannula 202 ispositionable, the implanting cannula 202 may be advanced distally untilthe distal end 234 is distal to the distal end 214 of the harvestingcannula 200. Next, the computer 120 operates the robotic arm 27 to placethe distal end 234 of the implanting cannula 202 adjacent to a targetlocation within an implant region of the patient as prescribed by thetreatment plan. The implanting cannula 202 is then advanced (e.g., byactivating a positioner within the positioning assembly 106, or bymoving the positioning assembly 106 distally towards the targetlocation) to pierce through the skin 310 at the implant region (FIG.11A). The implanting cannula 202 is advanced until the penetrated depth312 is at least equal to the coring depth 300. In some embodiments, thecamera(s) 28 and the computer 120 may be used to determine an amount ofthe implanting cannula 202 that has been advanced into the patient. Forexample, the implanting cannula 202 may include a plurality of markerlines for allowing the camera(s) 28 or a physician to “see” how much ofthe implanting cannula 202 has been inserted into the patient. As shownin the figure, the implanting cannula 202 creates an opening 314 belowthe patient's skin 314, in which the follicular unit 302 may be placed.

Next, the harvesting cannula 200, which contains the harvestedfollicular unit 302, is advanced within the lumen 236 of the implantingcannula 202, until a top surface 320 of the follicular unit 302 is at orbelow the skin 310 at the implant region (FIG. 11B). Next, the plunger204 may be advanced distally (e.g., by using another positioner withinthe positioning assembly 106) until its distal end 244 engages with thefollicular unit 302 located within the harvesting cannula 200 (FIG.11C). The implanting cannula 202 and the harvesting cannula 200 are thenretracted proximally relative to the plunger 204, thereby leaving thefollicular unit 302 implanted at the target location in the implantregion (FIG. 11D). In other embodiments, the cannula assembly 110 doesnot include the plunger 204. In such cases, a pressure generator (notshown) located within the positioning assembly 106 may be used to createa pressure within the lumen 217 of the harvesting cannula 200, therebypushing the follicular unit 302 towards the patient as the implantingcannula 202 and the harvesting cannula 200 is retracted. Such techniquewill cause the follicular unit 302 to dislodge from the harvestingcannula 200 while the harvesting cannula 200 is being removed from thepatient.

After the first follicular unit 302 has been implanted in the implantregion, the harvesting cannula 200 is advanced distally until its distalend 214 is distal to the distal end 234 of the implanting cannula 202.The computer 120 then operates the robotic arm 27 again to place theharvesting cannula 200 next to another target follicular unit 302 to beharvested. The above described process is then repeated to harvest thenext follicular unit 302, and to implant the follicular unit 302. Theselection of the follicular unit 302 may be determined by the computer120. For example, in some embodiments, based on a location and geometryof the prescribed harvest region, the computer 120 selects a follicularunit 302 only if it is within the prescribed harvest region. In someembodiments, the above process is repeated until a prescribed number offollicular units 302 have been implanted in the implant region, until adensity of the implanted follicle units 302 reaches a prescribeddensity, or until there is no more available follicular unit 302 in theharvest region.

In some embodiments of the invention employing an automated positioningsystem, an attending physician or operator may still specify where afollicular unit needs to be implanted and at what angle, i.e., itsrelative location (or “implantation site”), orientation, and depth. Forexample, specification of a location, orientation, and/or depth of afollicular unit to be implanted may be carried out by a treatmentplanning system. Alternatively, during the implanting mode, when thecamera(s) are viewing the recipient area of the scalp, the attendingoperator may use a user interface (e.g., a conventional computer mouse)to specify the implant location and/or position and/or orientationand/or implant depth. Alternatively, the operator can point to locationon the scalp by placing a temporary fiducial, such as an ink mark or apointer that can be visualized, identified, and measured by the imageprocessing system. Further, orientation can be specified directly on thecomputer monitor as a combination of two angles, such as rotation aboutx-axis and a rotation about y-axis (assuming that z-axis is along thecannula), or by placing an elongated pointer on the scalp, which theimage processing system can visualize and measure the angles.

In any case, the control of the robotic arm now becomes two steps.First, based on the specification of the location and orientation of theimplant location, the computer processor directs the robotic arm to movethe implanting cannula to a desired location and orientation. Second,the actual advancement of the implanting cannula into the skin surfacetakes place, either solely by actuating the mechanism, or by acombination of robotic arm movement and mechanism actuation, in whichthe desired implant depth is achieved. Another way of specifying theorientation of the implanted follicular unit is to have the system matchto the orientation of the one or more hair follicles extending therefrom to the orientation of existing hair follicles in the area ofimplantation. The system, after positioning the implanting cannula atthe implantation location, visualizes and measures the orientation ofneighboring hair follicles, and uses this information to determine anappropriate orientation of the follicular unit being implanted. In thecase of neighboring hair follicles having different orientations, thesystem may, for example, obtain a weighted average of the variousorientations for determining an orientation of the follicular unit beingimplanted.

The forgoing illustrated and described embodiments of the invention aresusceptible to various modifications and alternative forms, and itshould be understood that the invention generally, as well as thespecific embodiments described herein, are not limited to the particularforms or methods disclosed, but also cover all modifications,equivalents and alternatives falling within the scope of the appendedclaims. By way of non-limiting example, it will be appreciated by thoseskilled in the art that the invention is not limited to the use of arobotic system, and that other automated, semi-automated, and manualsystems and apparatus may be used for positioning and actuating therespective components of the multi-part tool assembly adjacent the bodysurface.

1. An automated system for harvesting and implanting hair, comprising: amoveable arm; and a multi-part tool assembly coupled to the moveablearm, wherein the moveable arm is maneuverable to position the toolassembly relative to a donor or implant region, the tool assemblycomprising an implanting cannula having a distal end and a lumen, aharvesting cannula positioned in the lumen of the implanting cannula,the harvesting cannula having a distal end and a lumen sized to receivea follicular unit, and one or more motors configured to providetranslational movement of at least one of the implanting and harvestingcannulas relative to the other, wherein when harvesting follicularunits, the distal end of the implanting cannula is located proximal tothe distal end of the harvesting cannula.
 2. The automated system ofclaim 1, the tool assembly further comprising an obturator positioned inthe lumen of the harvesting cannula, the one or more motors furtherconfigured to provide controlled linear translation of at least one ofthe obturator or the harvesting cannula relative to the other.
 3. Theautomated system of claim 2, wherein the implanting cannula andobturator are movable relative to the harvesting cannula and relative toeach other.
 4. The automated system of claim 1, wherein at least aportion of an interior wall of the harvesting cannula is texturized. 5.The automated system of claim 1, wherein at least one of the one or moremotors is further configured for rotating the harvesting cannula aboutits longitudinal axis.
 6. The automated system of claim 2, wherein theimplanting cannula, harvesting cannula, and obturator are coaxiallyaligned along a common axis.
 7. The automated system of claim 1, whereinthe automated system is a robotic system, and wherein the moveable armis a robotic arm.
 8. The automated system of claim 1, further comprisinga source of negative pressure in selective fluid communication with theharvesting cannula lumen.
 9. The automated system of claim 1, whereinone or both of the implanting and harvesting cannulas are removable fromthe multi-part tool assembly.
 10. The automated system of claim 1,further comprising a processor, the processor configured to a) controloperation of the one or more motors and/or b) determine relativepositions of the harvesting and implanting cannulas.
 11. The automatedsystem of claim 1, wherein the harvesting cannula is adapted to moverelative to the body surface by one or more of (1) movement of theharvesting cannula relative to the tool assembly, (2) movement of themoveable arm, or (3) movement of the harvesting cannula relative to themoveable arm.
 12. An automated system for harvesting and implantinghair, comprising: a moveable arm; and a multi-part tool assembly coupledto the moveable arm, wherein the moveable arm is maneuverable toposition the tool assembly relative to a donor or implant region, thetool assembly comprising an implanting cannula having a distal end and alumen, a harvesting cannula positioned in the lumen of the implantingcannula, the harvesting cannula having a distal end and a lumen sized toreceive a follicular unit, and one or more motors configured to providetranslational movement of at least one of the implanting and harvestingcannulas relative to the other, wherein the distal end of the implantingcannula is advanced over the harvesting cannula to puncture a recipientarea in the implant region to form an implantation cavity therein. 13.The automated system of claim 12, the tool assembly further comprisingan obturator positioned in the lumen of the harvesting cannula, the oneor more motors further configured to provide controlled lineartranslation of at least one of the obturator or harvesting cannularelative to the other.
 14. The automated system of claim 12, wherein theimplanting cannula, harvesting cannula, and obturator are coaxiallyaligned along a common axis.
 15. The automated system of claim 12,wherein at least one of the one or more motors are further configuredfor rotating the harvesting cannula about its axis.
 16. The automatedsystem of claim 12, wherein the automated system is a robotic system,and wherein the moveable arm is a robotic arm.
 17. The automated systemof claim 12, further comprising a source of negative pressure inselective fluid communication with the harvesting cannula lumen.
 18. Theautomated system of claim 13, wherein one or both of the implanting andharvesting cannulas are removable from the multi-part tool assembly. 19.The automated system of claim 12, further comprising a processor, theprocessor configured to a) control operation of the one or more motorsand/or b) determine relative positions of the harvesting and implantingcannulas.
 20. The automated system of claim 12, further comprising apositioning assembly for engaging the multi-part tool.